UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000002522
Receipt number R000003043
Scientific Title Effect of parathyroidectomy on oxidative stress in patients with secondary hyperparathyroidism
Date of disclosure of the study information 2009/10/01
Last modified on 2015/10/27 14:18:35

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Basic information

Public title

Effect of parathyroidectomy on oxidative stress in patients with secondary hyperparathyroidism

Acronym

Effect of parathyroidectomy on oxidative stress in patients with secondary hyperparathyroidism

Scientific Title

Effect of parathyroidectomy on oxidative stress in patients with secondary hyperparathyroidism

Scientific Title:Acronym

Effect of parathyroidectomy on oxidative stress in patients with secondary hyperparathyroidism

Region

Japan


Condition

Condition

Secondary hyperparathyroidism

Classification by specialty

Endocrinology and Metabolism Nephrology Endocrine surgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To determine the effect of parathyroidectomy on oxidative stress

Basic objectives2

Others

Basic objectives -Others

To determine the effect of parathyroidectomy on oxidative stress

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Change from baseline in oxidative stress markers

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

Parathyroidectomy

Interventions/Control_2


Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

18 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients with end stage renal disease receiving long-term hemodialysis
Patients with secondary hyperparathyroidism requiring parathyroidectomy
Patients who provide informed consent for the study

Key exclusion criteria

Patients who are unfit for general anaesthesia
Unstable medical condition
Currently enrolled another investigational device or drug
Pregnancy or breast feeding

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Masafumi Fukagawa

Organization

Kobe University School of Medicine

Division name

Division of Nephrology and Kidney Center

Zip code


Address

7-5-2 Kusunoki-cho, Chuo-ku, Kobe, Japan

TEL

078-382-6500

Email



Public contact

Name of contact person

1st name
Middle name
Last name Hirotaka Komaba

Organization

Kobe University School of Medicine

Division name

Division of Nephrology and Kidney Center

Zip code


Address

7-5-2 Kusunoki-cho, Chuo-ku, Kobe, Japan

TEL

078-382-6500

Homepage URL


Email

hkomaba@med.kobe-u.ac.jp


Sponsor or person

Institute

Kobe University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Japan Dialysis Outcome Research
ROD-21 Clinical Research Group

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2009 Year 10 Month 01 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2009 Year 09 Month 01 Day

Date of IRB


Anticipated trial start date

2009 Year 10 Month 01 Day

Last follow-up date

2010 Year 12 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2009 Year 09 Month 18 Day

Last modified on

2015 Year 10 Month 27 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003043


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name